How those [21st Century Cures’] provisions are implemented will matter a lot, and there is still a lot of work to do.
The 21st Century Cures legislation -- which passed the Congress by an overwhelming bipartisan margin and was swiftly signed into law by former President Obama -- includes broad provisions and funding to accelerate the development and delivery of innovative cures for diseases.
Perhaps what should be of most interest to providers regarding their health information (IT) systems were several regulatory changes included in the law. Specifically, the law deregulates five specific categories of health IT and establishes new requirements for health IT interoperability.
The bill excludes five categories of health IT from regulation by the FDA. These five categories have previously been subject to regulation by FDA under its “medical device authority.”
The law also allows health IT vendors to participate in patient safety organizations (PSOs), which allow the sharing and aggregating of adverse event data with protection from liability. This is an important change for which McKesson advocated.
In terms of health IT interoperability, the law requires vendors and providers to attest that they are not blocking information exchange. The law also provides a way for the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) to enforce the information blocking prohibition with civil penalties. How this requirement is defined and enforced through the regulatory rulemaking process will be critical.
As with any broad healthcare law, the devil is in the details, and much of the real policymaking is done by the regulatory agencies. In the case of this Cures legislation, those agencies are: HHS, the Centers for Medicare & Medicaid (CMS) and the Office of the National Coordinator for Health IT (ONC).
That’s why President Trump’s recent regulatory freeze is significant. Shortly after taking office, President Trump signed an executive order freezing all new and pending federal regulations. That order caused HHS to announce that over a dozen regulations -- including many related to 21st Century Cures implementation -- were being delayed.
This regulatory freeze means that rulemaking to implement provisions associated with the 21st Century Cures legislation may be delayed until HHS is fully staffed and key appointees are confirmed for the ONC, the FDA, and other departments of the Administration. HHS Secretary Tom Price and newly confirmed CMS Administrator Seema Verma will also bring their own perspective as to how these rules are implemented. For example, Secretary Price has been an outspoken critic of the way the ONC implemented the EHR certification program, and of health IT regulations in general.
The long and short of it is that 21st Century Cures contains many provisions that will impact our business, our customers and the industry. How those provisions are implemented will matter a lot, and there is still a lot of work to do.
Now back to your regularly scheduled repeal and replace debate.
This is part two of a three-part series on how the new administration will impact healthcare and health IT. If you missed the first post in this series, Six Key General Observations from the 2016 Election, read it here.